Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06587100

Conditions

Hematopoietic Neoplasm

Malignant Solid Neoplasm

Lymphatic System Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fitbit

Apple HealthKit-based devices

Study Details

Brief summary:

This study is being done to collect patient generated health data to predict the risk of patients needing emergency department visits or hospitalization before, during. and after receiving radiation therapy.

Conditions

Hematopoietic Neoplasm

Malignant Solid Neoplasm

Lymphatic System Neoplasm

Study ID

NCT06587100

Start date

Apr 7, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 18.
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky Performance Scale (KPS) ≤ 50%.
  • Able to understand study procedures and to comply with them for the entire length of the study.
  • Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
  • Diagnosis of invasive malignancy.
  • Able to ambulate independently (without the assistance of a cane or walker).
  • Planned treatment with fractionated external beam radiotherapy over at least 5 days (no fractional requirement).
  • Not a previous participant on this protocol for subsequent courses.

Exclusion Criteria:

  • Participants bound to a wheelchair.
  • Participants unable to ambulate independently (needing assistance of cane or walker).

Study Design

Enrollment

260 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational Group I: Fitbit only

Participants receive Fitbit device while undergoing non-interventional, standard of care, radiation therapy.

Observational Group II: Fitbit + Apple HealthKit

Participants receive Fitbit device and will utilize personal Apple HealthKit-based devices (iPhone, Apple Watch, etc.) to concurrently contribute Apple HealthKit-based data while undergoing non-interventional, standard of care, radiation therapy.

Interventions

Fitbit

Participants will wear Fitbit device

Apple HealthKit-based devices

Participants will wear personal device and share data with study team.

Primary outcome measure

  • Area under the receiver operating characteristic curve (AUC-ROC) of the step count model [ Time Frame: Up to 3 years ]
  • Calculation of a Brier Score [ Time Frame: Up to 3 years ]
  • Calculation of Log-Loss Score [ Time Frame: Up to 3 years ]
  • Area Under the Precision-Recall Curves (AUCPR) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Imani Dunn

877-827-3222Imani.Dunn@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Imani Dunn

877-827-3222Imani.Dunn@ucsf.edu

cancertrials@ucsf.edu

Principal Investigator:

Julian Hong, MD, MS

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Activity tracking
  • Hospitalization prevention
  • Artificial Intelligence (AI) modelling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-20.